Disinfectant Qualification

A controlled medical device manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness for use. Proper rotation of the disinfectants can be determined based on the data collected in this study.

Why should I choose Accuratus to perform my disinfectant qualification study?

  • Accuratus has been performing microbiological work for more than 25 years.
  • Our specialized microbiology group possesses years of experience performing qualification work on many different surface types using a wide range of disinfectants.
  • Accuratus has an internal collection of ATCC organisms ready for use onsite, plus the ability to identify and cryopreserve client environmental isolates.

How do I know which method to follow for my disinfectant testing study?

Tube Dilution Method

  • For clients with new facilities with little or no environmental trending history.
  • Utilizes ATCC strains and some environmental isolates, where applicable.
  • Isolates are directly inoculated into the desired concentration of disinfectant being tested.
  • Studies of this sort allow a facility to begin production with some assurance that their disinfectants can kill specific microorganisms of concern.
  • Initial screening of disinfectants does not validate that they are effective on hard surfaces.

Coupon Testing Using the Immersion Recovery Method

  • For established facilities with environmental programs and trending.
  • Coupons are prepared from representative surfaces present in the client’s clean room environment.
  • The disinfectants are sprayed on the surfaces using the method and contact time captured in the client’s cleaning procedures.
  • To ensure implementation of a proper disinfection program, the FDA recommends the use of the facility’s environmental isolates. However ATCC organisms may be used as well.

Accuratus can create a proposal for your disinfectant qualification study with the following information:

  • Quantity of surface materials found in your facility to be used in the study
  • Quantity of environmental isolates/ATCC strains to be used in the study
  • Quantity of disinfectants to be challenged in study
  • Quantity of exposure time-points to be challenged in the study (time disinfectant sits on a given surface)

Contact Us with any questions.  We are happy to take you through the disinfectant testing process.